December 17, 2014

expert reaction to new milestone in mitochondrial donation

Following a review by the Human Fertilisation and Embryology Authority (HFEA), draft regulations on mitochondrial donation have been announced. All our previous output on this subject can be seen here.

Prof. Doug Turnbull, Professor of Neurology at Newcastle University said:

“I am delighted that the Government considers that the time is now right to give Parliament the opportunity to consider and vote on these regulations. This is good news for patients with mitochondrial disease and I hope we are a step closer to being able to offer this new IVF technique to prevent transmission of this disease.”

Dr Frances Rawle, Director of Policy at the Medical Research Council said: 

“We’re very pleased the Government has today started a process to allow the fantastic advances in mitochondrial donation research to be trialed in humans once the HFEA decides there is sufficient evidence of their safety. First trials of any treatment in humans always present some risks, but regulations allowing the use of these technologies, with HFEA approval, will mean families and their doctors can decide whether the potential benefits for them are worthwhile. Their participation in the next stage of the research will add to what we know and will further benefit other families similarly affected.”

Mr Robert Meadowcroft, Chief Executive of the Muscular Dystrophy Campaign said:

“Today’s news is an important milestone for families affected by mitochondrial disease. For years many have been hoping for access to this IVF technique and a debate in Parliament is a huge step forward towards achieving this. This technique has moved successfully through the necessary ethical and public reviews, and a positive result in this debate is now vital to allow further progress.

“This is a complex issue, understandably generating strong views both in support and opposition. Mitochondrial transfer IVF involves a calculated step into new scientific territory, but it is a very focused step, with the sole aim of preventing a potentially fatal condition from being passed down to the next generation, where possible. For women who have been dealt the heavy blow of living with mitochondrial disease, the prospect of bearing healthy children is of immeasurable value. We believe that this technique could open up the possibility of motherhood untainted by the fear of passing on a painful, debilitating condition to their future children.

“It is now time to encourage our supporters, families and individuals living with mitochondrial disease, and indeed all those in support of the technique, to contact their MPs and make sure they understand the full human benefit of moving forward with mitochondrial donation IVF.”

Dr Jeremy Farrar, Director of the Wellcome Trust said:

“Over the past seven years, Britain has been engaged in an exemplary process for evaluating scientific, ethical and public opinion about mitochondrial donation, which has revealed broad support on all three fronts. A parliamentary vote is the next logical step, and we urge MPs to support regulations that will allow the law to catch up with public and scientific opinion. Parents who know what it means to care for a sick and suffering child with mitochondrial disease are the people best placed to decide, with proper medical advice and safeguards, whether mitochondrial donation is right for them. They should not have to wait any longer to be able to make this choice.”

Mr James Lawford Davies, Partner, Lawford Davies Denoon said:

“The draft regulations do not permit PNT or MST, and do not allow these techniques to be used – rather, they permit the HFEA to consider applications for licences permitting the use of these techniques in treatment. This is an important distinction: if the draft regulations become law, it does not follow that the HFEA will grant licences for the techniques to be used imminently, or indeed at all (though I hope that they will).  As with all licence applications, the HFEA will consider whether the proposed activity is safe, and whether the applicant has the necessary staff, expertise, skill and equipment to perform the proposed activity.  The draft Regulations simply allow this further review process to begin.”

Prof. Mary Herbert, Professor of Reproductive Biology, Newcastle University said:

“We are delighted that the government is taking this forward. The research in Newcastle is progressing quickly now, thanks to all those women who are continuing to support us by donating their eggs. We are confident that, should the regulations be approved, we will be soon be in a position to offer these procedures to couples who wish to make this reproductive choice.”

Mr Alastair Kent OBE, Director of Genetic Alliance UK said:

“Extensive public consultation has shown overwhelming support for making mitochondrial donation available, when it is safe enough to consider using, as it is a much needed option for families to avoid having children affected by these often devastating mitochondrial diseases. We are therefore pleased that these regulations have been laid before Parliament, and with the expectation that they are approved, we look forward to assisting the Human Fertilisation and Embryology Authority with their sensitive implementation.”

Ms Sarah Norcross, Director of the Progress Educational Trust said:

“Policy and regulation need to keep pace with scientific developments. For families affected by mitochondrial diseases, the government’s progress has been frustratingly slow. It’s not before time that these regulations will be debated in Parliament, and patients will be one step closer to being able to access treatment.”

http://www.legislation.gov.uk/ukdsi/2015/9780111125816/contents/

Declared interests

None declared